Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study (DEEP)
2021年3月8日 更新者：AtriCure, Inc.
Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF.
The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure.
This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.
研究概览
研究类型
介入性
注册 (实际的)
24
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
Stanford、California、美国、94305
- Stanford University Medical Center
-
-
Tennessee
-
Nashville、Tennessee、美国、37232
- Vanderbilt Heart Institute
-
-
Texas
-
Plano、Texas、美国、75093
- Baylor Health
-
-
Virginia
-
Charlottesville、Virginia、美国、22908
- UVA
-
Norfolk、Virginia、美国、23507
- Sentara Norfolk
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age > 18 years
- Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
- Patient is willing and able to provide written informed consent.
- Patient has a life expectancy of at least 2 years.
- Patient is willing and able to attend the scheduled follow-up visits.
Exclusion Criteria:
- Prior Cardiothoracic Surgery.
- Patient has NYHA Class IV heart failure.
- Evidence of underlying structural heart disease requiring surgical treatment.
- Ejection fraction < 30%
- Measured left atrial diameter > 6.0 cm
- Renal Failure
- Stroke within previous 6 months.
- Known carotid artery stenosis greater than 80%.
- Evidence of significant active infection or endocarditis.
- Pregnant woman or women desiring to become pregnant in the next 24 months.
- Presence of thrombus in the left atrium determined by echocardiography.
- History of blood dyscrasia.
- Contraindication to anticoagulation, based on Investigator's opinion.
- Mural thrombus or tumor.
- Moderate to Severe COPD
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：AtriCure Bipolar System combined with a catheter ablation
procedure using the AtriCure Bipolar System plus a catheter ablation
|
AtriCure Bipolar System plus a catheter ablation
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary Safety Endpoint
大体时间：Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
|
Acute MAE within 30 days post procedure or hospital discharge (up to 7 days), whichever is longer.
|
Within the first 30 days post-index procedure, or hospital discharge (up to 7 days), whichever is longer.
|
|
Absence of Atrial Fibrillation
大体时间：12 month follow-up
|
Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.
|
12 month follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Serious Device or Procedure Related Adverse Event Rate
大体时间：12 month follow-up
|
12 month follow-up
|
|
|
Acute Procedure Success
大体时间：Upon completion of the index procedure, up to ten hours
|
Upon completion of the index procedure, up to ten hours
|
|
|
Absence of Atrial Fibrillation
大体时间：After the 3 month blanking period through twelve month follow-up.
|
Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.
|
After the 3 month blanking period through twelve month follow-up.
|
|
Number of Participants With Reintervention to Address Atrial Dysrhythmia
大体时间：12 months
|
Number of Participants with Reintervention to Address Atrial Dysrhythmia, through 12 months
|
12 months
|
|
Number of Participants With DC Cardioversion
大体时间：12 months
|
12 months
|
|
|
Improvement in AF
大体时间：12 months
|
Improvement in Atrial Fibrillation Symptom Checklist Frequency (Minimum value: -1.0, Maximum value: 25.0) and Severity Scores (Minimum value: -6.0, Maximum value: 19.0)
|
12 months
|
|
Duration of Procedure
大体时间：During index procedure
|
During index procedure
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年12月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2013年11月1日
研究注册日期
首次提交
2010年11月22日
首先提交符合 QC 标准的
2010年11月22日
首次发布 (估计)
2010年11月23日
研究记录更新
最后更新发布 (实际的)
2021年4月1日
上次提交的符合 QC 标准的更新
2021年3月8日
最后验证
2016年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.